CDSCO UID MFG/MD/2021/000368_dd9e936185c45bb38483da5470752fd4_f466b3956e974bf015ceb3e29c44a73c

Sirolimus Eluting Coronary Stent System

Veritas Bioventions Pvt. Ltd·Device Class Class D·India CDSCO·Brand: Endorser, Patron, Hotron, Flextron
Registration details
UID
MFG/MD/2021/000368_dd9e936185c45bb38483da5470752fd4_f466b3956e974bf015ceb3e29c44a73c
Device class
Class D
Brand name
Endorser, Patron, Hotron, Flextron
Approving authority
Central Drug Standards Control Organization, Ahmedabad
Product information
The Coronary Stent is indicated for selective implantation and for treatment of acute or threatened closure following intervention in the coronary vasculature, including saphenous vein grafts & is intended to improve coronary luminal diameter. The issues of repeated restenosis are always big problem in metallic stent and to overcome this issue Drug eluting Stents (Endorser, Patron, Hotron, Flextron) are use for angioplasty. The Sinew Sirolimus eluting coronary stent system (Endorser, Patron, Hotron, Flextron) is indicated for use in patients with symptomatic ischemic heart disease due to discrete de novo coronary artery lesions with a reference vessel. Diameter ranging from 2.00 mm to 4.50 mm and is intended to improve coronary luminal diameter
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About this record

Sirolimus Eluting Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000368_dd9e936185c45bb38483da5470752fd4_f466b3956e974bf015ceb3e29c44a73c. This device is marketed under the brand name Endorser, Patron, Hotron, Flextron. The license holder is Veritas Bioventions Pvt. Ltd, and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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